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BRAF Inhibitor

Immunotherapy + Targeted Therapy for Melanoma

Phase 3

Waitlist Available

Led By Michael B Atkins

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age >= 18 years. Because no dosing or adverse event data are currently available on the use of dabrafenib or dabrafenib + trametinib or nivolumab or nivolumab + ipilimumab therapy in patients < 18 years of age, children are excluded from this study, but will be eligible for future pediatric trials.

Age >= 18 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial is testing two different treatments for melanoma that cannot be removed by surgery. The first treatment is immunotherapy with monoclonal antibodies, followed by targeted therapy with dabrafenib and trametinib. The second treatment is targeted therapy with dabrafenib and trametinib, followed by immunotherapy with monoclonal antibodies. It is not yet known which treatment is more effective.

Who is the study for?

Adults with stage III-IV melanoma that can't be surgically removed and have the BRAFV600 mutation. They should not have HIV, other cancers within the last 5 years (except certain skin cancers), serious medical conditions, or be pregnant/breastfeeding. Participants must agree to use effective contraception.Check my eligibility

What is being tested?

The trial is testing two treatment sequences for advanced melanoma: starting with ipilimumab and nivolumab (immunotherapies) followed by dabrafenib and trametinib (targeting BRAFV600 gene), versus starting with dabrafenib and trametinib followed by immunotherapies, to see which is more effective.See study design

What are the potential side effects?

Possible side effects include immune system reactions affecting organs, infusion-related reactions from antibodies, heart issues due to targeted therapies, liver problems, skin rash, fever, fatigue, eye problems like blurred vision or dry eyes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I am 18 years old or older.

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My cancer is at an advanced stage and cannot be removed with surgery.

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My cancer has a BRAF V600 mutation confirmed by an approved test.

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I am fully active or restricted in physically strenuous activity but can do light work.

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My melanoma cannot be removed by surgery and has been confirmed by tests.

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My melanoma has the BRAF V600 mutation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Overall survival (OS) rate

Secondary outcome measures

Progression-free survival (PFS)

Response rate

Toxicity rate for categorized AEs

+2 more

Other outcome measures

Change in patient-reported symptoms

Genetic characteristics

Immune-related adverse events (irAE) status

+2 more

Trial Design

4Treatment groups

Experimental Treatment

Group I: Arm D (immunotherapy)Experimental Treatment8 Interventions

IMMUNOTHERAPY INDUCTION (CYCLES 1-2): Patients receive nivolumab IV over 30-60 minutes and ipilimumab IV over 30-90 minutes on days 1 and 22. Treatment repeats every 6 weeks for 2 cycles in the absence of disease progression or unacceptable toxicity. IMMUNOTHERAPY MAINTENANCE (CYCLES 3-14): Patients receive nivolumab IV over 30-60 minutes on days 1, 15, and 29. Treatment repeats every 6 weeks for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT at baseline, and day 1 of cycles 3-14. Patients undergo ECHO or MUGA at end of treatment.

Group II: Arm C (BRAF inhibitor therapy)Experimental Treatment8 Interventions

Patients receive dabrafenib mesylate PO BID and trametinib dimethyl sulfoxide PO daily on days 1-42. Cycles repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo CT at baseline, and day 1 of each cycle. Patients undergo ECHO or MUGA day 1 of each cycle and end of treatment.

Group III: Arm B (BRAF inhibitor therapy)Experimental Treatment8 Interventions

Patients receive dabrafenib mesylate PO BID and trametinib dimethyl sulfoxide PO daily on days 1-42. Cycles repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. Upon disease progression (or before), patients re-register and cross over to Arm D. Patients undergo CT at baseline, and day 1 of each cycle. Patients undergo ECHO or MUGA day 1 of each cycle and end of treatment.

Group IV: Arm A (immunotherapy)Experimental Treatment8 Interventions

IMMUNOTHERAPY INDUCTION (CYCLES 1-2): Patients receive nivolumab IV over 30-60 minutes and ipilimumab IV over 30-90 minutes on days 1 and 22. Treatment repeats every 6 weeks for 2 cycles in the absence of disease progression or unacceptable toxicity. IMMUNOTHERAPY MAINTENANCE (CYCLES 3-14): Patients receive nivolumab IV over 30-60 minutes on days 1, 15, and 29. Treatment repeats every 6 weeks for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Upon disease progression (or before), patients re-register and cross over to Arm C. Patients undergo CT at baseline, and day 1 of cycles 3-14. Patients undergo ECHO or MUGA at baseline and end of treatment.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biospecimen Collection

2004

Completed Phase 2

~1730

Computed Tomography

2017

Completed Phase 2

~2720

Dabrafenib Mesylate

2014

Completed Phase 2

~10

Echocardiography

2013

Completed Phase 4

~11670

Electrocardiogram

2014

Completed Phase 2

~3060

Ipilimumab

2014

Completed Phase 3

~2670

Trametinib Dimethyl Sulfoxide

2014

Completed Phase 2

~10

Nivolumab

2014

Completed Phase 3

~4750

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,654 Previous Clinical Trials

40,932,853 Total Patients Enrolled

4 Trials studying Cutaneous Melanoma

198 Patients Enrolled for Cutaneous Melanoma

Michael B AtkinsPrincipal InvestigatorECOG-ACRIN Cancer Research Group

Media Library

Dabrafenib Mesylate (BRAF Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02224781 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How does Quality-of-Life Assessment impact patients in the short and long run?

"There is some evidence from previous clinical trials to suggest that Quality-of-Life Assessment is safe, so it receives a score of 3."

Answered by AI

How does Quality-of-Life Assessment help researchers get a better understanding of patients?

"Quality-of-Life Assessment can improve the prognosis for patients struggling with unresectable melanoma, squamous cell carcinoma, and those at high risk of cancer recurrence."

Answered by AI

Are there other ongoing clinical trials that focus on Quality-of-Life Assessment?

"The first Quality-of-Life Assessment study was done in 2009 at Texas Children's Hospital. So far, there have been 646 completed clinical trials and 891 live clinical trials. Many of these live trials are based in Bardstown, Kentucky."

Answered by AI

Is recruitment for this clinical trial currently ongoing?

"Unfortunately, this trial is no longer taking patients. The listing was created on July 13th, 2015 and edited for the last time on October 4th, 2022. If you are interested in other studies, 855 trials for recurrent melanoma and 891 for Quality-of-Life Assessment are still admitting patients."

Answered by AI

Could you please tell us how many different facilities are participating in this research project?

"There are presently 100 locations where this clinical trial is running. Some notable locations are Bardstown, Post Falls and Las Vegas. To cut down on travel, make sure to enroll at a location near you."

Answered by AI

What is the total number of individuals who have signed up for this research project?

"This trial is no longer admitting patients. The listing for this trial was created on July 13th, 2015 and edited for the last time on October 4th, 2022. However, there are 855 other trials for recurrent melanoma and 891 for Quality-of-Life Assessment currently admitting patients."

Answered by AI